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effect of progesterone in natural frozen – thawed embryo transfer cycles

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History
# Registration date Revision Id
3 2021-03-18, 1399/12/28 176391
2 2021-03-04, 1399/12/14 174365
1 2011-09-22, 1390/06/31 4620
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  • Protocol summary

    Progesterone is a prerequisite for development of the endometrium and implantation of an embryo. Low levels of progesterone during early pregnancy may result in miscarriage. The study is designed as a prospective randomized clinical trial.100 patients undergoing frozen embryo transfer in natural cycle in Yazd research and clinical center for infertility between March 2011 to March 2012.Inclusion criteria: regular menstrual cycle, 208mm and a follicle 18mm are present on ultrasound, 10000 IU HCG is injected IM and in the day of hCG administration serum estradiol is assessed. Randomly, 50 patients as interventional group receive 100mg/day progesterone IM starting from 36 hour after HCG administration and continue until 10 weeks of gestation if pregnancy is occurred. Control group (50patients) is not received progesterone. In both groups cryopreserved embryo transfer is considered 5 days after the HCG administration. Clinical pregnancy and implantation rate is compared between two groups. (Implantation rate defined as the number of gestational sac observed by ultrasound at 4 weeks after embryo transfer per 100 embryos transferred).
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    پروژسترون عاملی ضروری برای تکامل اندومتر و لانه گزینی جنین است . سطوح پایین پروژسترون در طی مراحل اولیه حاملگی میتواند منجر به سقط شود.این مطالعه به صورت کارآزمایی بالینی تصادفی آینده نگر طراحی شده است. 100 بیمار از فاصله زمانی از اول فروردین سال90 تا فروردین سال 91 در مرکز تحقیقاتی و درمانی ناباروری یزد تحت انتقال جنین فریز شده در سیکل طبیعی قرار می گیرند.معیارورود: سیکل قاعدگی مرتب؛ سن بین 20 تا 40 سال. معیار خروج: تخمک اهدایی؛آندومتریوز.همه بیماران در روز دهم سیکل قاعدگی تحت سونوگرافی واژینال قرار می گیرند و در صورتی که نیاز باشد تکرار می شود. وقتی که در سونوگرافی ضخامت آندومتر بیش از 8 میلی متر باشد و یک فولیکول 18 میلی متری وجود داشته باشد، 10000 واحد HCG به صورت عضلانی تزریق می شودو در روز تزریق HCG استرادیول سرم اندازه گیری می شود. به صورت تصادفی50 بیمار به عنوان گروه مطالعه روزانه 100میلی گرم پروژسترون به صورت عضلانی دریافت می کنند که 36 ساعت بعد از تزریق HCG شروع می شود و در صورت وقوع حاملگی تا هفته 10 ادامه می یابد.گروه کنترل (50 بیمار) پروژسترون دریافت نمی کنند. در هر دو گروه انتقال جنین فریز شده 5 روز بعد از تزریق HCG انجام می شود. حاملگی کلینیکال و میزان لانه گزینی بین دو گروه مقایسه می شود. (میزان لانه گزینی به صورت تعداد ساک حاملگی مشاهده شده به وسیله سونوگرافی4 هفته بعد از انتقال جنین به ازاء100 جنین منتقل شده تعریف می شود).
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    Better endometrial development and increased pregnancy rate
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    تکامل بهتر اندومتر و افزایش میزان حاملگی
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    A clinical trial with a randomized parallel control group with 102 patients. Participants participated in the study between March 2011 and March 2012 and were followed up to 20 weeks of gestation.
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    کارازمایی بالینی دارای گروه کنترل موازی تصادفی با 102 بیمار ،شرکت کنندگان بین تاریخ اسفند 1389 تا اسفند 1390 در مطالعه شرکت کردند و تا 20 هفته بارداری پیگیری شدند
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    En Yazd Research and Clinical Center for infertility affiliated to Shahid Sadoughi University of Medical Sciences
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    مرکز تحقیقاتی و درمانی ناباروری یزد,دانشگاه علوم پزشکی شهید صدوقی یزد
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    Inclusion critera: cryopreserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI); maternal age of 20-40 years (on the day of embryo freezing); regular menstrual cycle of 25-35 days; body mass index of 20-27 kg/m2 Exclusion critera:the use of testicular sperm for ICSI (ejaculated sperm only); basal follicle stimulating hormone; stage III-IV endometriosis; polycystic ovarian syndrome (PCOS)
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    شرایط ورود:جنین های رزرو شده بعد از لقاح آزمایشگاهی معمولی (IVF) یا تزریق اسپرم داخل سیتوپلاسمی (ICSI)؛ سن مادر 20-40 سال (در روز انجماد جنین)؛ چرخه قاعدگی منظم 25 تا 35 روز؛ شاخص توده بدن 20 -27 کیلوگرم در متر شرایط خروج: استفاده از اسپرم بیضه برای ICSI (فقط اسپرم انزالی)؛ (FSH) levels ≥12 IU/l ؛ اندومتریوز مرحله III-IV؛ سندرم تخمدان پلی کیستیک (PCOS)
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    The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred. Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
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    گروه پروژسترون 100 میلی گرم در روز پروژسترون (شرکت دارویی Aburaihan ، تهران ، ایران) IM دریافت کردند که 36 ساعت پس از تجویز hCG شروع شد و در صورت بروز حاملگی تا ده هفته بارداری ادامه داشت. بیماران شاهد هیچ پروژسترون دریافت نکردند. در هر دو گروه ، انتقال جنین منجمد با یک کاتتر Cook (Cook Ireland Ltd.) پنج روز پس از تجویز hCG انجام شد. سطح β-hCG سرم 14 روز پس از انتقال اندازه گیری شد.
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    The main outcome measures concerned clinical pregnancy and implantation rates
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    پیامد اصلی مربوط به حاملگی بالینی و میزان لانه گزینی بود

  • General information

    IVF
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    102
    2011-03-21, 1390/01/01
    2011-03-01, 1389/12/10
    2012-03-20, 1391/01/01
    2012-03-01, 1390/12/11
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    2011-03-01, 1389/12/10
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    2012-03-01, 1390/12/11
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    2012-03-01, 1390/12/11
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    update as result
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    بروزرسانی جهت نتایج
    cryop reserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
    maternal age of 20-40 years (on the day of embryo freezing)
    regular menstrual cycle of 25-35 days
    body mass index of 20-27 kg/m2
    جنین های رزرو شده بعد از لقاح آزمایشگاهی معمولی (IVF) یا تزریق اسپرم داخل سیتوپلاسمی (ICSI)
    age سن مادر 20-40 سال (در روز انجماد جنین)
    چرخه قاعدگی منظم 25 تا 35 روز
    شاخص توده بدن 20 -27 کیلوگرم در متر
    the use of testicular sperm for ICSI (ejaculated sperm only)
    basal follicle stimulating hormone
    stage III-IV endometriosis
    polycystic ovarian syndrome (PCOS)
    استفاده از اسپرم بیضه برای ICSI (فقط اسپرم انزالی)
    (FSH) levels ≥12 IU/l
    اندومتریوز مرحله III-IV
    سندرم تخمدان پلی کیستیک (PCOS)
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    Patients were randomized to either group in a ratio of 1:1 by means of computer-generated random numbers on the day of participation. Group selection and randomization were performed by a nurse not involved in the study, by using opaque sealed envelopes. Both the patients and the clinicians were aware of the allocated arm.
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    بیماران با استفاده از اعداد تصادفی رایانه ای تولید شده در روز مشارکت به هر گروه در نسبت 1: 1 تصادفی شدند. انتخاب گروه و تصادفی سازی توسط پرستاری که در مطالعه درگیر آن نبوده است ، با استفاده از پاکت های مات و مهر و موم شده انجام شد. هم بیماران و هم پزشکان از بازوی اختصاص یافته آگاهی داشتند.
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    100 patients
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    100 بیمار
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  • Secondary outcomes

    #1
    5 weeks after embryo transfer
    4-5 weeks after embryo transfer
    5 هفته پس از انتقال جنین
    4-5 هفته پس از انتقال جنین

  • Intervention groups

    #1
    In interventional group (50 patients) patients undergo transvaginal ultrasound on day 10 of cycle and are repeated as needed. When endometrial thickness >8mm and a follicle 18mm are present on ultrasound, 10000 IU HCG is injected and In the day HCG administration serum estradiol is assessed.36 hour after HCG administration patients receive 100mg/day progesterone IM and continue until 10 weeks of gestation if pregnancy is occurred. The cryopreserved embryo transfer is considered 5 days after the HCG administration.
    On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
    در گروه مطالعه (50 نفر ) بیماران در روز دهم سیکل قاعدگی تحت سونوگرافی واژینال قرار می گیرند و در صورتی که نیاز باشد تکرار می شود. وقتی که در سونوگرافی ضخامت آندومتر بیش از 8میلی متر باشد و یک فولیکول 18 میلی متری وجود داشته باشد، 10000 واحد HCG به صورت عضلانی تزریق می شودو در روز تزریق HCG استرادیول سرم اندازه گیری می شود. 36 ساعت بعد از تزریق HCG بیماران روزانه 100میلی گرم پروژسترون به صورت عضلانی دریافت می کنند و در صورت وقوع حاملگی تا هفته 10 ادامه می یابد. انتقال جنین فریز شده 5 روز بعد از تزریق HCG انجام می شود.
    در روزهای دوم یا سوم چرخه قاعدگی ، همه بیماران تحت سونوگرافی از طریق واژن و آنالیز هورمون سرم برای FSH قرار گرفتند. سپس ، معاینه سونوگرافی واژن در روزهای 10 سیکل انجام شد و در صورت لزوم تکرار شد. بلوغ نهایی تخمک با تزریق عضلانی (IM) 10000 IU hCG (پرگنیل ، داروپخش ، ایران) هنگامی که ضخامت آندومتر 8 میلی متر یا بیشتر و فولیکول 18 میلی متر در سونوگرافی وجود داشت ، حاصل شد. در روز تجویز hCG ، ما سطح استروادیول ‚پروژسترون و LH را اندازه گیری کردیم. گروه پروژسترون 100 میلی گرم در روز پروژسترون (شرکت دارویی Aburaihan ، تهران ، ایران) IM دریافت کردند که 36 ساعت پس از تجویز hCG شروع شد و در صورت بروز حاملگی تا ده هفته بارداری ادامه داشت. در هر دو گروه ، انتقال جنین منجمد با یک کاتتر Cook (Cook Ireland Ltd.) پنج روز پس از تجویز hCG انجام شد. سطح β-hCG سرم 14 روز پس از انتقال اندازه گیری شد.
    #2
    In control group (50 patients) patients undergo transvaginal ultrasound on day 10 of cycle and are repeated as needed. When endometrial thickness >8mm and a follicle 18mm are present on ultrasound, 10000 IU HCG is injected and in the day HCG administration serum estradiol is assessed. Control group is not received progesterone .The cryopreserved embryo transfer is considered 5 days after the HCG administration
    In control group :On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
    در گروه کنترل (50 نفر) بیماران در روز دهم سیکل قاعدگی تحت سونوگرافی واژینال قرار می گیرند و در صورتی که نیاز باشد تکرار می شود. وقتی که در سونوگرافی ضخامت آندومتربیش از 8 میلی متر باشد و یک فولیکول 18 میلی متری وجود داشته باشد، 10000 واحد HCG به صورت عضلانی تزریق می شودو در روز تزریق HCG استرادیول سرم اندازه گیری می شود.این گروه پروژسترون دریافت نمی کنند. انتقال جنین فریز شده 5 روز بعد از تزریق HCG انجام می شود.
    در گروه کنترل: در روزهای دوم یا سوم چرخه قاعدگی ، همه بیماران تحت سونوگرافی از طریق واژن و آنالیز هورمون سرم برای FSH قرار گرفتند. سپس ، معاینه سونوگرافی واژن در روزهای 10 سیکل انجام شد و در صورت لزوم تکرار شد. بلوغ نهایی تخمک با تزریق عضلانی (IM) 10000 IU hCG (Pregnyl ، داروپخش ، ایران) هنگامی که ضخامت آندومتر 8 میلی متر یا بیشتر و یک فولیکول 18 میلی متر در سونوگرافی وجود داشت ، حاصل شد. در روز تجویز hCG ، ما سطح استروادیول ‚پروژسترون و LH را اندازه گیری کردیم. بیماران تحت کنترل هیچ پروژسترون دریافت نکردند. در هر دو گروه ، انتقال جنین منجمد با یک کاتتر Cook (Cook Ireland Ltd.) پنج روز پس از تجویز hCG انجام شد. سطح β-hCG سرم 14 روز پس از انتقال اندازه گیری شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Yazd research and clinical center for infertility
    Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Dr Maryam Eftekhar
    Full name of responsible person - Persian: خانم دکتر افتخار
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد ,
    City - English: Yazd
    City - Persian: یزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Yazd research and clinical center for infertility
    Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Dr Maryam Eftekhar
    Full name of responsible person - Persian: خانم دکتر افتخار
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد ,
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax: +98 35 3824 7085
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Dr Maryam Eftekhar
    Full name of responsible person - Persian: خانم دکتر افتخار
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد
    City - English: Yazd
    City - Persian: یزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vice-Chancellor for Research & Technology
    Full name of responsible person - Persian: معاون تحقیقات و فناوری
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax: +98 35 3824 7085
    Email: Eftekhar@ssu.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
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    Academic
    Yazd research and clinical center for infertility
    Yazd University of Medical Sciences
    مرکز تحقیقاتی و درمانی ناباروری یزد
    دانشگاه علوم پزشکی یزد

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Dr Mozhgan Rahsepar
    Full name of responsible person - Persian: دکتر مژگان راهسپار
    Position - English: Obestetrics and Gynecologist,Student of fellowship
    Position - Persian: متخصص زنان وزایمان؛دانشجوی فلوشیپ
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد ,
    City - English: Yazd
    City - Persian: یزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile:
    Fax:
    Email: drrahsepar@hotmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Mozhgan Rahsepar
    Full name of responsible person - Persian: دکتر مژگان راهسپار
    Position - English: Obestetrics and Gynecologist,Student of fellowship
    Position - Persian: متخصص زنان وزایمان؛دانشجوی فلوشیپ
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد ,
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 912 450 1801
    Fax: +98 35 1824 7085
    Email: drrahsepar@hotmail.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Dr Maryam Eftekhar
    Full name of responsible person - Persian: خانم دکتر افتخار
    Position - English: Obestetrics and Gynecologist, fellowship of infertility
    Position - Persian: متخصص زنان وزایمان ؛فلوشیب نازایی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد
    City - English: Yazd
    City - Persian: یزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile:
    Fax:
    Email: eftekharmaryam@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Maryam Eftekhar
    Full name of responsible person - Persian: خانم دکتر افتخار
    Position - English: Obestetrics and Gynecologist, fellowship of infertility
    Position - Persian: متخصص زنان وزایمان ؛فلوشیب نازایی
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
    Street address - Persian: یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax: +98 35 1824 7085
    Email: eftekharmaryam@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Maryam Eftekhar
    Full name of responsible person - Persian: دکتر مریم افتخار
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Boali Street, Safaieh, Yazd, Research and clinical center
    Street address - Persian: یزد-صفاییه-خیابان بوعی- مرکز ناباروری
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Sharing plan

    undecided
    yes
    yes
    undecided
    yes
    no
    no
    empty
    Due to the privacy of patients
    empty
    به علت حفظ حریم خصوصی بیماران
    empty
    Information on the main outcome
    empty
    ا اطلاعات مربوط به پیامد اصلی
    empty
    6 months after printing the results
    empty
    6 ماه پس از چاپ نتایج
    empty
    Editor-in-Chief
    empty
    سردبیر مجله
    empty
    use in the retrospective study
    empty
    استفاده در مطالعات گذشته نگر
    empty
    Yazd research and clinical center for infertility
    empty
    مرکز تحقیقات ناباروری یزد
    empty
    Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, request is referred to the research experts and then get the data.
    empty
    درخواست از معاونت پژوهشی ، مطرح شدن در شورای پژوهشی مرکز ناباروری ،درصورت قبول درخواست ارجاع به حراست مرکز و تکمیل فرمهای مربوطه، ارجاع به کارشناس پژوهشی و دریافت داده ها

  • Trial results

    No
    Yes
    empty
    2021-03-08, 1399/12/18
    empty
    2013-04-01, 1392/01/12
    empty
    https://www.ijfs.ir/article_45164.html

    Table 1

    Characteristics of patients

    Outcome variable Progesterone N=51 No progesterone N=51 P value
    Age (Years) 29.0 ± 3.8 28.7 ± 4.6 0.71
    BMI (kg/m2) 23.8 ± 2.8 24.3 ± 2.4 0.35
    Duration of infertility (Years) 6.0 ± 3.8 6.7 ± 4.5 0.71
    Basal FSH (IU/L) 5.8 ± 1.9 6.0 ± 2.0 0.90
    Previous ART attempts n (%) 14 (27.5) 17 (33.3) 0.51
    Etiology of infertility n (%) 0.62
    Male factor 35 (68.6) 32 (62.7)
    Tubal factor 7 (13.8) 6 (11.8)
    Unexplained 9 (17.6) 13 (25.5)

     

     

    Table 2

    Patients’ previous fresh cycle characteristics

    Outcome variable Progesterone N=51 No progesterone N=51 P value
    Type of previous stimulation n (%) 0.84
    Agonist protocol 29 (56.9) 31(60.8)
    Antagonist protocol 22 (43.1) 20 (39.2)
    Fertilization procedure n (%)
    IVF 11 (21.6) 19 (37.3)
    ICSI 40 (78.4) 32 (62.7)
    No. of oocytes retrieved 10.0 ± 4.3 9.6 ± 3.4 0.16
    No. of mature oocytes 8.3 ± 3.4 7.6 ± 2.8 0.22
    No. of embryos obtained 6.2 ± 1.6 5.7 ± 2.2 0.19
    No. of embryos vitrified 4.3 ± 1.0 4.0 ± 0.6 0.07
    Fertilization rate (%) 55.4 64.3 0.16
    Sperm parameters
    Count (mill/ml) 12.6 ± 7.7 11.9 ± 7.0 0.62
    Progressive motility (%) 15.0 ± 5.8 14.5 ± 6.9 0.72
    Normal morphology (%) 15.3 ± 9.8 14.2 ± 7.3 0.51
    Cause of embryo freezing n (%) 0.59
    Surplus embryos 30 (58.8) 26 (45.1)
    Risk of OHSS 19 (37.3) 21(41.2)
    Endometrial polyp 2 (3.9) 4 (7.8)

    Table 3

    Frozen-thawed embryo replacement cycle characteristics

    Outcome variable Progesterone N=51 No progesterone N=51 P value
    Endometrial thickness (mm) 8.7 ± 1.3 8.9 ± 1.4 0.64
    E2 on hCG day (pg/ml) 208.4 ± 60.2 median: 200 196.9 ± 85.3 median: 170 0.11
    Progesterone on hCG day (ng/ml) 0.77 ± 0.09 0.80 ± 0.07 0.08
    LH on hCG day (IU/L) 4.9 ± 1.9 4.6 ± 1.7 0.39
    No. of days until hCG 14.3 ± 1.8 13.7 ± 1.5 0.07
    No. of embryos transferred 1.7 ± 0.5 median: 2 1.9 ± 0.5 median: 2 0.07
    Transfers with good quality embryos (%) 54.9 60.8 0.54

    Table 4

    Pregnancy outcomes

    Outcome variable Progesterone N=51 No progesterone N=51 P value
    Chemical pregnancy rate‚ n (%) 18 (35.3) 16 (31.4) 0.83
    Clinical pregnancy rate‚ n (%) 17 (33.3) 14 (27.5) 0.66
    Implantation rate (%) 16.6 15.3 0.93
    Clinical abortion rate‚ n (%) 2 (11.8) 2 (14.3) 0.83

    empty
    Abstract Background: The transfer of cryopreserved embryos can be timed with ovulation in a natural cycle or after artificially preparing the endometrium with exogenous hormones. Progesterone is essential for the secretory transformation of the endometrium that permits implantation as well as maintenance of early pregnancy. The purpose of this study is to assess the effect of luteal phase supplementation on pregnancy rates in natural frozen-thawed cycles. Materials and Methods: The study was designed as a prospective randomized clinical trial of 102 women who underwent embryo transfers in natural cycles. The women in the interventional group (n=51) received intra muscular (IM) progesterone 50 mg twice a day starting from 36 hours after hCG administration. The control group (n=51) did not receive any progesterone support. Results: There were no significant differences in demographic characteristics between the groups and no statistically significant differences were observed between study and control groups in clinical pregnancy rate (33.3% vs. 27.5%, p=0.66). There were no differences in implantation rate or spontaneous abortion rate. Conclusion: Our results suggest that luteal phase support does not affect clinical pregnancy rates in natural frozen-thawed embryo transfer cycles (Registration Number: IRCT201108044339N6).
    empty
    خلاصه زمینه و هدف: انتقال جنین های منجمد می تواند با تخمک گذاری در یک چرخه طبیعی یا پس از آماده سازی مصنوعی آندومتر با هورمون های برون زا انجام شود. پروژسترون برای تبدیل آندومتر ترشحی که اجازه کاشت و همچنین حفظ اوایل بارداری را می دهد ، ضروری است. هدف از این مطالعه ارزیابی اثر مکمل فاز لوتئال بر میزان حاملگی در چرخه طبیعی جنین-ذوب شده است. مواد و روش ها: این مطالعه به عنوان یک کارآزمایی بالینی تصادفی آینده نگر بر روی 102 زن که در چرخه های طبیعی انتقال جنین ، طراحی شده است. زنان در گروه مداخله (51 نفر) از 36 ساعت پس از تجویز hCG ، پروژسترون داخل عضلانی (IM) 50 میلی گرم دو بار در روز دریافت کردند. گروه کنترل (51 نفر) هیچ پروژسترونی برای حمایت فاز لوتیال دریافت نکردند. یافته ها: از نظر مشخصات دموگرافیک بین دو گروه تفاوت معنی داری وجود نداشت و از نظر آماری تفاوت معنی داری بین میزان بارداری بالینی (33.3%در برابر 27.5%)p=0.66مشاهده نشد. هیچ تفاوتی در میزان لانه گزینی یا میزان سقط خود به خودی وجود نداشت. نتیجه گیری: نتایج ما نشان می دهد که حمایت از فاز لوتئال بر میزان حاملگی بالینی در چرخه انتقال جنین ذوب شده طبیعی ذوب شده تأثیر نمی گذارد. (شماره ثبت: IRCT201108044339N6)

Protocol summary

Study aim
Better endometrial development and increased pregnancy rate
Design
A clinical trial with a randomized parallel control group with 102 patients. Participants participated in the study between March 2011 and March 2012 and were followed up to 20 weeks of gestation.
Settings and conduct
En Yazd Research and Clinical Center for infertility affiliated to Shahid Sadoughi University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion critera: cryopreserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI); maternal age of 20-40 years (on the day of embryo freezing); regular menstrual cycle of 25-35 days; body mass index of 20-27 kg/m2 Exclusion critera:the use of testicular sperm for ICSI (ejaculated sperm only); basal follicle stimulating hormone; stage III-IV endometriosis; polycystic ovarian syndrome (PCOS)
Intervention groups
The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred. Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
Main outcome variables
The main outcome measures concerned clinical pregnancy and implantation rates

General information

Reason for update
update as result
Acronym
IVF
IRCT registration information
IRCT registration number: IRCT201108044339N6
Registration date: 2011-09-22, 1390/06/31
Registration timing: registered_while_recruiting

Last update: 2021-03-08, 1399/12/18
Update count: 2
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2012-03-01, 1390/12/11
Actual recruitment start date
2011-03-01, 1389/12/10
Actual recruitment end date
2012-03-01, 1390/12/11
Trial completion date
2012-03-01, 1390/12/11
Scientific title
effect of progesterone in natural frozen – thawed embryo transfer cycles
Public title
natural frozen – thawed embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cryop reserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) maternal age of 20-40 years (on the day of embryo freezing) regular menstrual cycle of 25-35 days body mass index of 20-27 kg/m2
Exclusion criteria:
the use of testicular sperm for ICSI (ejaculated sperm only) basal follicle stimulating hormone stage III-IV endometriosis polycystic ovarian syndrome (PCOS)
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 109
Actual sample size reached: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized to either group in a ratio of 1:1 by means of computer-generated random numbers on the day of participation. Group selection and randomization were performed by a nurse not involved in the study, by using opaque sealed envelopes. Both the patients and the clinicians were aware of the allocated arm.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd research and clinical center for infertility
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
929

Health conditions studied

1

Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility

Primary outcomes

1

Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
BHCG TEST

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
4-5 weeks after embryo transfer
Method of measurement
Obestetrics sonography

Intervention groups

1

Description
On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
Category
Treatment - Drugs

2

Description
In control group :On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research & Technology
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7085
Email
Eftekhar@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mozhgan Rahsepar
Position
Obestetrics and Gynecologist,Student of fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7085
Email
drrahsepar@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Maryam Eftekhar
Position
Obestetrics and Gynecologist, fellowship of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7085
Email
eftekharmaryam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Maryam Eftekhar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Boali Street, Safaieh, Yazd, Research and clinical center
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Email
eftekhar@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Editor-in-Chief
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
Yazd research and clinical center for infertility
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, request is referred to the research experts and then get the data.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2021-03-08, 1399/12/18
Table of baseline comparison

Table 1

Characteristics of patients

Outcome variable Progesterone N=51 No progesterone N=51 P value
Age (Years) 29.0 ± 3.8 28.7 ± 4.6 0.71
BMI (kg/m2) 23.8 ± 2.8 24.3 ± 2.4 0.35
Duration of infertility (Years) 6.0 ± 3.8 6.7 ± 4.5 0.71
Basal FSH (IU/L) 5.8 ± 1.9 6.0 ± 2.0 0.90
Previous ART attempts n (%) 14 (27.5) 17 (33.3) 0.51
Etiology of infertility n (%) 0.62
Male factor 35 (68.6) 32 (62.7)
Tubal factor 7 (13.8) 6 (11.8)
Unexplained 9 (17.6) 13 (25.5)

Participant flow diagram

 

 

Table of variable outcomes' results

Table 2

Patients’ previous fresh cycle characteristics

Outcome variable Progesterone N=51 No progesterone N=51 P value
Type of previous stimulation n (%) 0.84
Agonist protocol 29 (56.9) 31(60.8)
Antagonist protocol 22 (43.1) 20 (39.2)
Fertilization procedure n (%)
IVF 11 (21.6) 19 (37.3)
ICSI 40 (78.4) 32 (62.7)
No. of oocytes retrieved 10.0 ± 4.3 9.6 ± 3.4 0.16
No. of mature oocytes 8.3 ± 3.4 7.6 ± 2.8 0.22
No. of embryos obtained 6.2 ± 1.6 5.7 ± 2.2 0.19
No. of embryos vitrified 4.3 ± 1.0 4.0 ± 0.6 0.07
Fertilization rate (%) 55.4 64.3 0.16
Sperm parameters
Count (mill/ml) 12.6 ± 7.7 11.9 ± 7.0 0.62
Progressive motility (%) 15.0 ± 5.8 14.5 ± 6.9 0.72
Normal morphology (%) 15.3 ± 9.8 14.2 ± 7.3 0.51
Cause of embryo freezing n (%) 0.59
Surplus embryos 30 (58.8) 26 (45.1)
Risk of OHSS 19 (37.3) 21(41.2)
Endometrial polyp 2 (3.9) 4 (7.8)

Table 3

Frozen-thawed embryo replacement cycle characteristics

Outcome variable Progesterone N=51 No progesterone N=51 P value
Endometrial thickness (mm) 8.7 ± 1.3 8.9 ± 1.4 0.64
E2 on hCG day (pg/ml) 208.4 ± 60.2 median: 200 196.9 ± 85.3 median: 170 0.11
Progesterone on hCG day (ng/ml) 0.77 ± 0.09 0.80 ± 0.07 0.08
LH on hCG day (IU/L) 4.9 ± 1.9 4.6 ± 1.7 0.39
No. of days until hCG 14.3 ± 1.8 13.7 ± 1.5 0.07
No. of embryos transferred 1.7 ± 0.5 median: 2 1.9 ± 0.5 median: 2 0.07
Transfers with good quality embryos (%) 54.9 60.8 0.54

Table 4

Pregnancy outcomes

Outcome variable Progesterone N=51 No progesterone N=51 P value
Chemical pregnancy rate‚ n (%) 18 (35.3) 16 (31.4) 0.83
Clinical pregnancy rate‚ n (%) 17 (33.3) 14 (27.5) 0.66
Implantation rate (%) 16.6 15.3 0.93
Clinical abortion rate‚ n (%) 2 (11.8) 2 (14.3) 0.83

Table of adverse events
First publication date
2013-04-01, 1392/01/12
Abstract of published paper
Abstract Background: The transfer of cryopreserved embryos can be timed with ovulation in a natural cycle or after artificially preparing the endometrium with exogenous hormones. Progesterone is essential for the secretory transformation of the endometrium that permits implantation as well as maintenance of early pregnancy. The purpose of this study is to assess the effect of luteal phase supplementation on pregnancy rates in natural frozen-thawed cycles. Materials and Methods: The study was designed as a prospective randomized clinical trial of 102 women who underwent embryo transfers in natural cycles. The women in the interventional group (n=51) received intra muscular (IM) progesterone 50 mg twice a day starting from 36 hours after hCG administration. The control group (n=51) did not receive any progesterone support. Results: There were no significant differences in demographic characteristics between the groups and no statistically significant differences were observed between study and control groups in clinical pregnancy rate (33.3% vs. 27.5%, p=0.66). There were no differences in implantation rate or spontaneous abortion rate. Conclusion: Our results suggest that luteal phase support does not affect clinical pregnancy rates in natural frozen-thawed embryo transfer cycles (Registration Number: IRCT201108044339N6).
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